Page 12 - Assurance of Sterility for Sensitive Combination Products and Materials

2 Assurance of sterility for sensitive combination products and materials

The regulatory evolution of combination products has provided man-
ufacturers with an opportunity to envision a new subset of products that
utilize various combinations of medical devices, biologics, pharmaceuticals,
active electronics, and/or bioresorbables in unique manners. Therefore, the
regulatory climate for combination products necessitated the use of a blend
of requirements that would be specific for the appropriate combination of
medical device, biologics, and/or pharmaceutical products.
Until recently, healthcare products were typically classified as medical
devices, biologics, or pharmaceuticals. The different classifications of prod-
ucts were traditionally regulated through different parts of regulatory agen-
cies, which have for years operated independently. The requirements for
different categories of products did not typically involve coordination across
agencies. The development of combination products has required that man-
ufacturers as well as regulators learn to navigate the diverse requirements
across the different agencies.
A successful sterility assurance professional—with the convergences of
this changing regulatory landscape—requires the ability to connect the dots
across the different sectors of the industry that have traditionally, all too
often, been in silos. Combination products may need terminal sterilization
and/or aseptic processing; and sterilization professionals need to understand
both. The majority of healthcare risks to patients include those associated
with healthcare facilities themselves; hence, sterilization professionals need
to understand how the product is used in the healthcare facilities and the
magnitude of hospital-acquired infections (HAI).
One of the unique value streams of this book is its perspective integrat-
ing discussion of sterility assurance topics across industry sectors. This pres-
ents a terminology challenge since different sectors use different but related
terminology. This is addressed as follows.

1.2 Sterility assurance terminology

The term ‘sterile’ is generally defined as an absolute state, for example, the
absence of viable microorganisms. Different terms are used in different sterility
assurance sectors as follows:
Sterility assurance level (SAL) is specific to terminal sterilization, defined
as the “probability of a single viable microorganism occurring on an
item after sterilization.”
Probability of a non-sterile unit (PNSU) is sometimes used for termi-
nally sterilized components feeding into an aseptic process.